Appendix A
Biographic Information on the Committee on Toxicity Testing and Assessment of Environmental Agents

Daniel Krewski (Chair) is professor of medicine and of epidemiology and community medicine and director of the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa. Previously, he served as director of risk management and as director of the Bureau of Chemical Hazards with Health Canada. Dr. Krewski is associate editor of Risk Analysis. His research interests include epidemiology, biostatistics, risk assessment, and risk management. He serves on National Research Committee (NRC) Committee on Health Risks from Exposure to Low Levels of Ionizing Radiation (BEIR VII Phase 2). He has previously served on the NRC Board on Environmental Studies and Toxicology, the Board on Radiation Effects Research, the Committee on Toxicology, the Committee on Pesticides in the Diets of Infants and Children, the Subcommittee on Pharmacokinetics, the Committee on Comparative Toxicity of Naturally Occurring Carcinogens, the Subcommittee on Health Assessment of Ingested Fluoride, and the Subcommittee on Acute Exposure Guideline Levels. He recently chaired the NRC’s Colloquium on Scientific Advances and the Future in Toxicologic Risk Assessment. Dr. Krewski has published more than 400 journal articles and book chapters on risk assessment, biostatistics, and epidemiology. He received his MSc and PhD in mathematics and statistics from Carleton University and his MHA from the University of Ottawa.


Daniel Acosta, Jr., is dean of the College of Pharmacy at the University of Cincinnati. Dr. Acosta’s research focuses on the development of in vitro cellular models to explore and evaluate the mechanisms by which xenobiotics damage cell types. He has worked to develop primary culture



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Toxicity Testing for Assessment of Environmental Agents: Interim Report Appendix A Biographic Information on the Committee on Toxicity Testing and Assessment of Environmental Agents Daniel Krewski (Chair) is professor of medicine and of epidemiology and community medicine and director of the McLaughlin Centre for Population Health Risk Assessment at the University of Ottawa. Previously, he served as director of risk management and as director of the Bureau of Chemical Hazards with Health Canada. Dr. Krewski is associate editor of Risk Analysis. His research interests include epidemiology, biostatistics, risk assessment, and risk management. He serves on National Research Committee (NRC) Committee on Health Risks from Exposure to Low Levels of Ionizing Radiation (BEIR VII Phase 2). He has previously served on the NRC Board on Environmental Studies and Toxicology, the Board on Radiation Effects Research, the Committee on Toxicology, the Committee on Pesticides in the Diets of Infants and Children, the Subcommittee on Pharmacokinetics, the Committee on Comparative Toxicity of Naturally Occurring Carcinogens, the Subcommittee on Health Assessment of Ingested Fluoride, and the Subcommittee on Acute Exposure Guideline Levels. He recently chaired the NRC’s Colloquium on Scientific Advances and the Future in Toxicologic Risk Assessment. Dr. Krewski has published more than 400 journal articles and book chapters on risk assessment, biostatistics, and epidemiology. He received his MSc and PhD in mathematics and statistics from Carleton University and his MHA from the University of Ottawa. Daniel Acosta, Jr., is dean of the College of Pharmacy at the University of Cincinnati. Dr. Acosta’s research focuses on the development of in vitro cellular models to explore and evaluate the mechanisms by which xenobiotics damage cell types. He has worked to develop primary culture

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Toxicity Testing for Assessment of Environmental Agents: Interim Report systems of liver, heart, kidney, nerve, skin, and eye cells as experimental models to study the cellular and subcellular toxicity of selected xenobiotics. He was elected president of the Society of Toxicology, 2000-2001, and is editor of Toxicology In Vitro and the Target Organ Series on Cardiovascular Toxicology. Dr. Acosta serves as chair of the Food and Drug Administration (FDA) Scientific Advisory Board for the National Center for Toxicology Research and was a member of the Board of Scientific Councilors for the Office of Research and Development for the Environmental Protection Agency (EPA) for 2001-2004. He was a member of the Scientific Advisory Committee to the director of the National Center for Environmental Health of the Centers for Disease Control (CDC) for 2001-2003. He is serving on the Scientific Advisory Committee for Alternative Toxicological Methods for the National Institute for Environmental Health Sciences (NIEHS), and the Expert Committee on Toxicology and Biocompatibility for the US Pharmacopoeia (2000-2005). He also served on the NRC Howard Hughes Medical Institute Predoctoral Fellowships Panel on Neurosciences and Physiology. Dr. Acosta received his PhD in pharmacology and toxicology from the University of Kansas. Melvin Andersen is director of the Computational Biology Division at the CIIT Centers for Health Research. Previously, he held positions in toxicology research and research management in the federal government (Department of Defense and EPA) and was professor of environmental health at Colorado State University. He has worked to develop biologically realistic models of the uptake, distribution, metabolism, and biologic effects of drugs and toxic chemicals and has applied these physiologically based pharmacokinetic and pharmacodynamic models to safety assessments and quantitative health risk assessments. His current research interests include developing mathematical descriptions of control of genetic circuitry in the developing and adult organism and the dose-response and risk-assessment implications of the control processes. Dr. Andersen is board-certified in industrial hygiene and in toxicology. He has served on numerous NRC committees, including the Committee on Toxicology, the Committee on Toxicological Effects of Mercury, the Committee on Risk Assessment Methodology, and the Subcommittee on Pharmacokinetics. He earned a PhD in biochemistry and molecular biology from Cornell University.

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Toxicity Testing for Assessment of Environmental Agents: Interim Report Henry Anderson is chief medical officer and state epidemiologist for occupational and environmental health in the Wisconsin Division of Public Health and adjunct professor of population health at the University of Wisconsin Medical School. Dr. Anderson’s research interests include disease surveillance, risk assessment, childhood asthma, lead poisoning, health hazards of Great Lakes sport fish consumption, arsenic in drinking water, bioterrorism, asbestos disease, vermiculite exposure, and occupational fatalities and injuries in youth. He is certified by the American Board of Preventive Medicine with a subspecialty in occupational and environmental medicine and is a fellow of the American College of Epidemiology. Dr. Anderson is chairperson of the Board of Scientific Councilors of the National Institute of Occupational Safety and Health (NIOSH) and has served as chairperson of the Environmental Health Committee of the EPA Scientific Advisory Board. He served on the NRC Committee on a National Agenda for the Prevention of Disabilities and the Committee on Enhancing Environmental Health Content in Nursing Practice. Dr. Anderson received his MD from the University of Wisconsin Medical School. John C. Bailar III is professor emeritus in the Department of Health Studies at the University of Chicago. He is a retired Commissioned Officer of the US Public Health Service and worked for the National Cancer Institute for 22 years. He has also held academic appointments at Harvard University and McGill University. Dr. Bailar’s research interests include assessing health risks posed by chemical hazards and air pollutants and interpreting statistical evidence in medicine, with emphasis on cancer. He was editor-in-chief of the Journal of the National Cancer Institute for 6 years, and was statistical consultant for and then member of the Editorial Board of the New England Journal of Medicine. Dr. Bailar is a member of the International Statistical Institute and was elected to the Institute of Medicine in 1993. He received his MD from Yale University and his PhD in statistics from American University. Kim Boekelheide is professor in the Department of Pathology and Laboratory Medicine at Brown University. His research interests are in male reproductive biology and toxicology, particularly the potential roles of germ-cell proliferation and apoptosis and local paracrine growth factors in the regulation of spermatogenesis after toxicant-induced injury. Dr. Boekelheide serves on the NRC Subcommittee on Fluoride in Drinking Water and has served on the Committee on Gender Differences in Sus-

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Toxicity Testing for Assessment of Environmental Agents: Interim Report ceptibility to Environmental Factors: A Priority Assessment. He is a past member of the Board of Scientific Counselors of the National Toxicology Program (NTP) and currently serves on the NTP Center for the Evaluation of Risks to Human Reproduction expert panel that is evaluating di-(2-ethylhexyl)phthalate. Dr. Boekelheide received his MD and PhD (Pathology) from Duke University and is Board Certified in Anatomic and Clinical Pathology. Robert Brent is Distinguished Professor of Pediatrics, Radiology, and Pathology at the Jefferson Medical College of Thomas Jefferson University and head of the Laboratory of Clinical and Environmental Teratology at the Alfred I. duPont Hospital for Children. Dr. Brent’s research focuses on the environmental and genetic causes of congenital malformations, genetic disease, and cancer, with an emphasis on reproduction and the toxicity of drugs, physical agents, and chemicals. Dr. Brent recently completed “The Vulnerability and Resiliency of the Developing Embryo, Infant, Child and Adolescent to the Effects of Environmental Chemicals, Drugs and Physical Agents as Compared to Adults” for the EPA and the American Academy of Pediatrics, which was published in Pediatrics in April 2004. He is a member of the Institute of Medicine. Dr. Brent received his MD with honors; a PhD in embryology, radiation biology, and physics; and an honorary DSc—all from the University of Rochester. Gail Charnley is principal of HealthRisk Strategies, her consulting practice in Washington, DC. Her interests are toxicology, environmental health risk assessment, and risk-management science and policy. During its tenure, she was executive director of the Presidential/Congressional Commission on Risk Assessment and Risk Management, mandated by Congress to evaluate the role that risk assessment and risk management play in federal regulatory programs. Before her appointment to the commission, she served as director of the toxicology and risk assessment program at the National Academies. She has been the project director for several NRC committees, including the Committee on Risk Assessment Methodology and the Complex Mixtures Committee, and served as the chair of several U.S. Army Science Advisory Board committees that evaluated health risk assessment. Dr. Charnley serves on the NRC Committee on Improving Practices for Regulating and Managing Low-Activity Radioactive Waste. She received her PhD in toxicology from the Massachusetts Institute of Technology.

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Toxicity Testing for Assessment of Environmental Agents: Interim Report Vivian G. Cheung is associate professor in the Department of Pediatrics and Genetics at the University of Pennsylvania School of Medicine and a member of the Cell and Molecular Biology and Genomics and Computational Biology Graduate Groups. Her primary research interests include human genome variation, DNA damage repair, and the use of genome-wide approaches to study the genetic basis of human phenotypes and traits. Her research techniques include genomic-mismatch scanning, sequence-mismatch detection, physical mapping, molecular fingerprinting, DNA microarrays, fluorescent image analysis, and developing genome databases. She earned her MD from Tufts University. Sidney Green, Jr., is graduate professor of pharmacology at Howard University College of Medicine. Dr. Green’s research interests include tissue culture, scientific and policy issues associated with alternatives, use of animals in toxicology, and mutagenic assay systems. He has served on the editorial boards of several scientific journals, and he is a fellow of the Academy of Toxicological Sciences. Dr. Green is a member of the NRC Committee on Toxicology and has served on several NRC panels, including the Subcommittee on Acute Exposure Guideline Levels, the Subcommittee on the Toxicity of Diisopropyl Methylphosphonate, and the Subcommittee on Iodotrifluoromethane. He received his PhD in biochemical pharmacology from Howard University. Karl T. Kelsey is professor of cancer biology and environmental health in the Departments of Genetics and Complex Diseases and Environmental Health at the Harvard School of Public Health. Dr. Kelsey’s research interests are in occupational and environmental disease, including susceptibility to disease, with emphasis on gene-environment interactions in the production of chronic disease, and the determinants of somatic gene inactivation in lung and upper airway cancers. He has been at the Harvard School of Public Health since 1987. Dr. Kelsey has served on numerous NRC committees, including the Committee on Copper in Drinking Water, the Committee to Review the Health Consequences of Service During the Persian Gulf War, and the Committee on the Health Effects of Mustard Gas and Lewisite. Dr. Kelsey received his MD from the University of Minnesota and an MOH from Harvard University. Nancy I. Kerkvliet is a professor in the Department of Environmental and Molecular Toxicology at Oregon State University (OSU). Dr. Kerkvliet also serves as the Associate Director of the Environmental Health Sciences Center at OSU as well as Director of the Flow Cytome-

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Toxicity Testing for Assessment of Environmental Agents: Interim Report try and Cell Sorting Facilities Core. Her research interests include the use of animal models to understand how chemicals alter immune function, particularly the mechanisms of action of polychlorinated dibenzo-p-dioxins and other aryl hydrocarbon receptor (AhR) ligands. Transgenic and gene-deletion approaches are being used, as well as genomics, to address mechanisms of AhR-mediated immunotoxicity. She is also active in public outreach education programs in toxicology and risk communication. Dr. Kerkvliet is a current member of the IOM Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides and is a past member of the NRC’s Committee on Toxicology. She has also served as a Councilor for the Society of Toxicology. She earned her PhD degree in interdisciplinary biological sciences and toxicology from OSU. Abby A. Li recently joined Exponent as a managing scientist/toxicologist in the Health Risk and Food and Chemical Practices. Her fields of research include toxicology, neurotoxicology, developmental neurotoxicology, psychopharmacology, risk assessment, and pesticide regulation. Previously, Dr. Li was a senior science fellow and a global regulatory science manager at Monsanto, providing expertise in toxicology and risk assessment to address regulatory scientific issues in different world areas. For more than 10 years, she led the neurotoxicology group at Monsanto’s Environmental Health Laboratory, where she conducted pharmacokinetic, toxicology, and neurotoxicology studies of industrial chemicals, agricultural products, and pharmaceuticals. Dr. Li served on the U.S. expert teams to the Organisation for Economic Cooperation and Development (OECD) for the development of international test guidelines for adult and developmental neurotoxicology and as chair of neurotoxicology expert groups for industry trade organizations (the American Chemistry Council’s long-range research program and the American Industrial Health Council) addressing scientific regulatory issues in neurotoxicology. Dr. Li was a member of the EPA’s Science Advisory Board’s Environmental Health Committee for 6 years, reviewing the lead rule, 1,3-butadiene risk assessment, trichloroethylene risk assessment, cancer guidelines, the IRIS database, development of acute reference exposure, methods for derivation of inhalation reference concentrations, and indoor air toxics priority-ranking. She is a member of the International Life Science Institute Agricultural Chemical Safety Assessment panel involved in redesign of safety assessment of pesticides. She received her PhD in pharmacology and physiology from the University of Chicago.

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Toxicity Testing for Assessment of Environmental Agents: Interim Report George Lucier is a consultant in toxicology. He is a senior adjunct scientist for Environmental Defense, an adviser to the NIEHS and the National Toxicology Program (NTP), and a member of the EPA’s Science Advisory Board. He retired from NIEHS in 2000 where he was director of the Environmental Toxicology Program, associate director of the NTP, and head of a research group in molecular epidemiology and dosimetry. In his NTP role, Dr Lucier was responsible for coordinating toxicologic research and testing across federal agencies including EPA, the FDA and the NIOSH. His research focused on the use of basic biology to reduce uncertainty in human risk assessments and to improve the tools used in exposure assessment. Dr Lucier was editor of Environmental Health Perspectives for 28 years and is still a consulting editor. He received his PhD from the University of Maryland School of Agriculture. Lawrence McCray is a research affiliate with the Massachusetts Institute of Technology (MIT), where he leads a project on the use of knowledge in decision-making and participates in other research on organizational performance and behavior in risk management. Dr. McCray was a staff director and a senior manager at the National Research Council, where he led many studies on U.S. science and technology policy programs, including the seminal study Risk Assessment in the Federal Government: Managing the Process, the so-called Red Book. Dr. McCray also served as head of the EPA Regulatory Reform Unit and a program director on regulatory reform in the Executive Office of the President. He earned a PhD in science and public policy from MIT and an MBA from Union College. Otto Meyer is head of the Section of Biology, Department of Toxicology and Risk Assessment, Danish Institute for Food and Veterinary Research. The section has overall responsibility for in vivo testing in the department, including repeated dose-toxicity studies, carcinogenicity studies, reproductive-toxicity studies, and neurotoxicity studies. He is the specialized expert to the European Economic Community on classification and labeling of dangerous substances with carcinogenic, mutagenic, or teratogenic properties and national coordinator of the Test Guideline Programme (human health) of the OECD. Concerning the latter commitment, Dr. Meyer is a member of the group preparing an OECD guidance document on reproductive toxicity and assessment. During the last 5 years, he has served as a member of the European Union Scientific Committee on Plant Protection Products (now named the Panel of Plant

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Toxicity Testing for Assessment of Environmental Agents: Interim Report Health), Plant Protection and their Residues under the European Food Safety Authority. Dr. Meyer earned a DVM from the Royal Veterinary and Agricultural University in Copenhagen. D. Reid Patterson retired in 2003 after almost 20 years of responsibility for the toxicity and safety assessment of the diverse portfolio of pharmaceutical, diagnostic, and hospital products for Abbott Laboratories; he is now a private consultant. During his tenure, he led the research efforts in toxicology, pathology, laboratory animal medicine, metabolism, pharmacokinetics, and analytic chemistry in an effort to characterize product hazards. Environmental toxicity was a greater focus during his earlier years in the petrochemical industry (Shell) and the contract laboratory business (Hazleton). Dr. Patterson is a veterinarian with residency training in laboratory animal medicine, and he received his PhD in comparative pathology from the University of Missouri. He is board-certified in laboratory animal medicine, veterinary pathology, and general toxicology, and he is a fellow of the Academy of Toxicological Sciences and the International Academy of Toxicologic Pathology. William Pennie is director of molecular and investigative toxicology with Pfizer Inc. Dr. Pennie’s research interests began with the molecular biology of the estrogen receptor, particularly differential transcriptional regulation by estrogen-receptor subtypes. More recently, his interests have included global receptor biology, improving the predictivity of investigative techniques used at early stages of product development, the technology and application of custom microarray toxicogenomics platforms, and the application of state-of-the-art molecular profiling techniques to research and investigative toxicology. He chairs the International Life Sciences Institute/Health and Environmental Sciences Institute (ILSI/HESI) Committee on the Application of Genomics to Mechanism-Based Risk Assessment. Dr. Pennie received his PhD from the Beatson Institute for Cancer Research at the University of Glasgow, Scotland. Robert A. Scala is former senior scientific adviser at Exxon Biomedical Sciences Inc. He is also an adjunct professor of toxicology at Rutgers University. He is well known for his work on the toxicity of gasoline components and chemical mixtures. He is a past president of the Society of Toxicology and the American Board of Toxicology. He has published in chronic toxicity testing and evaluation of alternative test protocols and

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Toxicity Testing for Assessment of Environmental Agents: Interim Report data. Dr. Scala has served on several NRC committees including the Committee on Environmental Justice: Research, Education, and Health Policy Needs, the Committee on Lead Toxicity, and the Committee on Methods for In Vivo Toxicity Testing of Complex Mixtures from the Environment. Dr. Scala earned his PhD in physiology from the University of Rochester School of Medicine and Dentistry. Gina M. Solomon is a senior scientist at the Natural Resources Defense Council (NRDC) and an assistant clinical professor of medicine at the University of California, San Francisco (UCSF), where she is also the Associate Director of the UCSF Pediatric Environmental Health Specialty Unit. Her work has included research on asthma, pesticides, and environmental and occupational threats to reproductive health and child development. Dr. Solomon serves on the EPA Science Advisory Board Drinking Water Committee and previously served on the Endocrine Disruptor Screening and Testing Advisory Committee. Dr. Solomon received her MD from Yale University and underwent her postgraduate training in medicine and public health at Harvard University. Martin Stephens is vice president of the Animal Research Issues Section of the Humane Society of the United States. Dr. Stephens serves as coordinator of the International Council for Animal Protection at the OECD. He also serves on the Scientific Advisory Committee on Alternative Toxicological Methods for the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and on the Scientific Advisory Panel of the Institute for In Vitro Sciences. Dr. Stephens has extensive experience in animal protection and in vitro testing sciences. He earned a PhD in biology from the University of Chicago. James Yager is professor of toxicology in the Department of Environmental Health Sciences, director of the NIEHS Training Program in Environmental Health Sciences, and senior associate dean for academic affairs at the Johns Hopkins University Bloomberg School of Public Health. Dr. Yager is a member and a past president of the carcinogenesis specialty section of the Society of Toxicology. His research focuses on the role of catechol metabolites of endogenous, synthetic, and environmental estrogens and polymorphisms in genes involved in estrogen metabolism as risk factors in the development of cancer of the breast and liver. Dr. Yager earned his PhD from the University of Connecticut.

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Toxicity Testing for Assessment of Environmental Agents: Interim Report Lauren Zeise is chief of the Reproductive and Cancer Hazard Assessment Branch of the California Environmental Protection Agency. She received her PhD from Harvard University. Dr. Zeise’s research focuses on modeling human interindividual variability and risk. She has served on advisory boards of the U.S. EPA, the World Health Organization, the Office of Technology and Assessment, and the NIEHS. She has also served on several NRC committees, including the Committee on Risk Characterization, the Committee on Comparative Toxicology of Naturally Occurring Carcinogens, the Committee on Copper in Drinking Water, and the Committee to Review EPA’s Research Grants Program. Dr. Zeise is a member of the Board on Environmental Studies and Toxicology and of the Institute of Medicine’s Health Promotion and Disease Prevention Board.